Development of Trazodone HCl Prolonged-Release Tablets: Formulation Optimization and Dissolution Studies

Abstract

The present study aimed to develop and optimize prolonged-release tablets of Trazodone HCl using hydrophilic hydroxypropyl methylcellulose (HPMC) polymers of different viscosity grades and concentrations to achieve controlled drug release over 24 hours. Tablets were prepared by the direct compression method using HPMC K4M, HPMC K15M, and HPMC K100M at varying concentrations, followed by evaluation of assay and in vitro dissolution. Drug release studies were performed using USP Apparatus II in 0.1 N HCl for the first hour and phosphate buffer (pH 6.0) thereafter. The results demonstrated that both polymer viscosity and concentration significantly influenced the release profile. Formulations containing HPMC K4M and HPMC K15M exhibited rapid drug release. They failed to control the initial burst effect, while a low concentration of HPMC K100M was insufficient to establish an effective matrix. Increasing the concentration of HPMC K100M improved release control, with an optimized batch containing 25% w/w HPMC K100M providing the most desirable dissolution profile, achieving 26.68%, 48.81%, 82.47%, and 100.42% cumulative drug release at 1, 6, 12, and 24 hours, respectively. Reproducibility studies confirmed consistent performance of the optimized formulation. Overall, the optimized batch was identified as the optimal formulation and represents a promising prolonged-release system suitable for further stability evaluation, process scale-up, and pharmaceutical development.